Bielenda Group S.A.
⚠️ High Risk
FEI: 3006231328 • Cracow, Malopolskie • POLAND
FEI Number
3006231328
Location
Cracow, Malopolskie
Country
POLANDAddress
Ul. Fabryczna 20, , Cracow, Malopolskie, Poland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 11/8/2023 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 11/8/2023 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 8/24/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 8/24/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 8/24/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 8/24/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 8/24/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 8/11/2015 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 8/11/2015 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 8/11/2015 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | New York District Office (NYK-DO) | |
| 8/11/2015 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 8/11/2015 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 8/11/2015 | 64DBJ99EMOLLIENT, LUBRICANT, N.E.C. | New York District Office (NYK-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 5/15/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 5/15/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 5/31/2011 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/31/2011 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bielenda Group S.A.'s FDA import refusal history?
Bielenda Group S.A. (FEI: 3006231328) has 30 FDA import refusal record(s) in our database, spanning from 5/31/2011 to 11/8/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bielenda Group S.A.'s FEI number is 3006231328.
What types of violations has Bielenda Group S.A. received?
Bielenda Group S.A. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Bielenda Group S.A. come from?
All FDA import refusal data for Bielenda Group S.A. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.